BCRL Prevention Pilot
Sleutelwoorden
Abstract
Omschrijving
Breast cancer related lymphedema occurs in 20-30% of survivors. Weight loss could prevent onset. We seek to do a pilot study to establish feasibility of 1) recruiting survivors at risk for lymphedema to do a weight loss intervention, 2) achieving 10-15% weight loss over 26 weeks in this population, and 3) attendance at follow-up visits 6 months.
Datums
Laatst geverifieerd: | 09/30/2012 |
Eerste ingediend: | 07/19/2010 |
Geschatte inschrijving ingediend: | 07/19/2010 |
Eerst geplaatst: | 07/20/2010 |
Laatste update ingediend: | 10/10/2012 |
Laatste update geplaatst: | 10/11/2012 |
Werkelijke startdatum van het onderzoek: | 06/30/2010 |
Geschatte primaire voltooiingsdatum: | 09/30/2012 |
Geschatte voltooiingsdatum van het onderzoek: | 09/30/2012 |
Conditie of ziekte
Fase
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie | 18 Years Naar 18 Years |
Geslachten die in aanmerking komen voor studie | Female |
Bemonsteringsmethode | Probability Sample |
Accepteert gezonde vrijwilligers | Ja |
Criteria | Inclusion Criteria: - Women - Breast Cancer Survivors who had 5 or more lymph nodes removed and radiation to lymph nodes as part of treatment. - Completed all treatments - no metastatic cancers - Overweight or obese (BMI greater than or equal to 25 kg/m2) - Medically and logistically able to participate in a weight loss and exercise program over 6 months. - Diagnosed with breast cancer within the past 2 years. Exclusion Criteria: - More than 2 years since breast cancer diagnosis - Medical status that would preclude safety of participation in a weight loss and exercise program - Metastatic cancer - Already enrolled in a weight loss program |
Resultaat
Primaire uitkomstmaten
1. Follow-up Appts. [6 months]
Secundaire uitkomstmaten
1. Response Rates [6 months]